IPOD-3: Effects of 3 Day Preoperative Immunonutrition in Well-nourished Patients With Gastrointestinal (GI) Cancer Undergoing Surgery
Study Details
Study Description
Brief Summary
Major surgery is still associated with a high rate of postoperative morbidity despite improved techniques in surgical management. Surgery-induced alterations of the immune system are well described and may play a role in the genesis of postoperative complications. It has been shown by several large scale clinical trials, that the use of immunonutrition in postoperative cancer surgery, trauma and critically ill patients resulted in an improved immunocompetence and/or reduced postoperatively infectious morbidity and/or length of hospital stay.The pre-operative regimen was between 5 to 7 days of treatment. The aim of this trial is to evaluate if a shorter administration of 3 days pre-operatively would be beneficial as well.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Nutritional product Oral nutritional supplement containing immuno nutrients |
Dietary Supplement: Immunonutrition
Oral Nutritional Supplement containing the amino acid arginine, omega-3 fatty acids, and nucleotides (RNA).
|
| Placebo Comparator: Isocaloric control Isocaloric and isonitrogenous control without immuno nutrients |
Dietary Supplement: Immunonutrition
Oral Nutritional Supplement containing the amino acid arginine, omega-3 fatty acids, and nucleotides (RNA).
|
Outcome Measures
Primary Outcome Measures
- Rate of post-operative complications [On the day of discharge from hospital]
Secondary Outcome Measures
- Incidence of non-infectious complications [On the day of discharge from hospital]
- Length of hospital stay [On the day of discharge from hospital]
- Nutritional status evaluation [On the day of discharge from hospital]
- Rate of post-operative infectious complications [On the day of discharge from hospital]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients with GI cancer (stomach, pancreas, small and large bowel and rectum) histologically proven
-
Well nourished patients as defined by a total score of <3 on the nutritional screening tool NRS-2002 (46) (Appendix III)
-
Patients who are >= 18 years of age;
-
Patients who have signed a written Informed Consent (Appendix I) prior to admission to the study;
-
Patients who have an ECOG performance status of 0, 1 or 2 (Appendix II).
-
Patients able to orally consume 750 mL or more of liquid a day prior to surgery
Exclusion Criteria:
-
Patients who have co-morbid conditions, uncontrolled metabolic conditions or psychiatric conditions that might make tolerance or evaluation of the feeding formula difficult;
-
Patients who are pregnant;
-
Patients with cardiac failure as defined by the Goldman classification class>3
-
Patients with respiratory failure (FEV<0.8l/sec)
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Patients with renal failure (Cr >= 3mg/dl or dialysis patients)
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Patients with hepatic dysfunction (Child >A)
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Patients suffering from an intestinal obstruction or ileum
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Patients with an Hb level of <=8 g/dL experiencing gastrointestinal hemorrhaging
-
Patients with HIV, HCV, HBV
-
Patients requiring immunosuppression treatments
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Patients undergoing emergency surgery
-
Other patients determined by a study investigator to be inappropriate for enrolment in this study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kantonsspital Aarau | Aarau | Switzerland | 5001 | |
| 2 | Kantonsspital Baden | Baden | Switzerland | 5404 | |
| 3 | Lindenhof-Spital | Bern | Switzerland | 3012 | |
| 4 | Kantonsspital Liestal | Liestal | Switzerland | 4410 | |
| 5 | Kantonsspital Schaffausen | Schaffhausen | Switzerland | 8208 | |
| 6 | Kantonsspital St.Gallen | St.Gallen | Switzerland | 9000 |
Sponsors and Collaborators
- Nestlé
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SC-IRTD-01-05-CH